Ceftaroline Diffusion Into Cerebrospinal Fluid of Children

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Ceftaroline fosamil is an intravenous (IV) drug that belongs to a group of antibiotics called cephalosporins . Antibiotics are drugs used to treat infections. Clinical studies in adults patient shave shown ceftaroline fosamil to be effective against many bacteria that are resistant to other currently approved antibiotics. Some of these bacteria may be responsible for infections in the central nervous system.The main aim of this study is to gather information to determine how much of a single IV dose of ceftaroline fosamil will enter into a child's CSF so that the benefit of giving ceftaroline fosamil to children with infections can be better determined.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Basim Asmar
• Collaborator: Forest Laboratories
• Treatments: Ceftaroline fosamil; Cephalosporins

Criteria

Inclusion Criteria:

• Age 6 months - 17 years

• Ventriculitis due to VPS infection (abnormal CSF parameters consistent with meningeal inflammation and/or positive CSF culture)

• VPS is externalized and External Ventriculostomy Drain (EVD) is in place

• Patient has IV access and is receiving antibiotic treatment for VPS infection

• Parent/Guardian signed written informed consent

• Negative urine or serum pregnancy test for females of child-bearing potential

Exclusion Criteria:

• Known Allergy to beta-lactam antibiotics

• Moderate to severe renal impairment (Creatinine clearance < 50mL/minute)

• Parent/Guardian written consent cannot be obtained

• Positive urine or serum pregnancy test